Transcatheter insertion device and method

ABSTRACT

The present invention relates to a transcatheter method for providing fluid communication between two anatomical compartments. The present invention also relates to a transcatheter system comprising an intracorporeal connector for fluid communication between two anatomical compartments through at least one anatomical wall, wherein said connector is adapted to receive a flow regulating device, a connector, a flow regulating device and an insertion device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of International patent applicationNo. PCT/EP2015/055578, filed on Mar. 17, 2015, which claims priority toforeign Norway patent application No. 20140353, filed on Mar. 17, 2014,and foreign United Kingdom patent application No. 1410320.4, thedisclosures of which are incorporated by reference in their entireties.

FIELD OF INVENTION

The present invention generally relates to the field of medical devicesand surgery devices. More specifically, the present invention relates toa transcatheter system and corresponding devices and methods oftreatment. The present invention is particularly useful as a mechanicalcirculatory support system for example for the treatment of circulatorycollapse, heart failure and heart conditions requiring a circulatoryassist device but also has a wider variety of applications.

BACKGROUND

Examples of mechanical circulatory support systems (MCS) includeventricular assist devices (VADs). A VAD is a mechanical pumping devicecapable of supporting heart function and blood flow. Specifically, a VADhelps one or both ventricles of the heart to pump blood trough thecirculatory system. Left ventricular assist devices (LVAD), rightventricular assist devices (RVAD) and biventricular assist devices(BiVAD) are currently available. Also, circulatory support systems mayinclude cardiopulmonary support (CPS, ECMO), which provide means forblood oxygenation as well as blood pumping. Such devices may be requiredduring, before and/or after heart surgery or to treat severe heartconditions such as heart failure, cardiopulmonary arrest (CPA),ventricular arrhythmia or cardiogenic shock.

Traditionally, VADs are fitted during open-heart surgery through anincision in the chest and the procedure involves puncturing the apex ofthe left ventricle to re-route blood from the ventricle to the aortathrough an external pump. An example of device used in surgical VAD isHeartMate II™. Such surgical procedures are clearly invasive andunsuitable for weaker and vulnerable patients as they involve a greaterrecovery time and carry the risks of infection and trauma. Thisparticularly the case in the treatment of children for whom existingsurgical equipments and devices are comparatively bulkier and moreinvasive, and a reduction of the size of the equipment is oftendifficult if not impossible in view of the equipment and procedureinvolved. Furthermore, these devices require the intervention from ateam of skilled surgical staff in a hospital environment and aretherefore less available and costly.

More recent procedures are non-surgical and involve the insertion of aVAD through a small incision made at the groin of the patient. A popularversion of such so-called percutaneous VAD is the TandemHeart™ device. Atube is introduced trough an incision adjacent the groin of the patientand advanced along the femoral vein and inferior vena cava, across theintra-atrial septum and into the left atrium so that oxygenated bloodfrom the left atrium is fed into a pumping device located outside thepatient's body and recirculated through an outflow tube into the femoralartery. Although this device has shown promising results, it onlyprovides short-term support (up to two weeks) and is unsuitable forlong-term treatments. The external pump is bulky and requires patient'simmobilization for as long as the device is fitted. Furthermore, thereis a risk of life-threatening infection around the groin incision, whichremains open during the treatment, and of considerable bleeding from amajor artery. In addition, the tube of the TandemHeart™ ends in the leftatrium from which blood is pumped out and led outside the patient'sbody. This type of blood inlet system can potentially become hindered,if not blocked, if surrounding tissues are accidentally sucked in,thereby resulting to a loss of efficiency.

Another popular percutaneous VAD is the Impella™ device, which isinserted into the femoral artery and descending aorta. The Impella™device comprises an elongated end, which is implanted across the naturalaortic valve, with a blood inlet placed in the left ventricle and ablood outlet above the aortic valve. A pump circulates blood from theinlet to the outlet. The driveline is externalised through the femoralartery during use and the same limitations apply as with TandemHeart™and other current percutaneous MCS systems. This device is approved toprovide support for up to a week. There is therefore a need for a devicewith reduced risk of infection and bleeding and increased mechanicalstability which can be used as part of a short-term “bridge to recovery”treatment or as a long-term treatment including patient mobilisation. Inaddition, the efficiency of the pump is limited because it is notpossible to insert a pump of the size required to provide a suitableblood flow using percutaneous arterial access. Presently, the problem oflimited pump capacity and duration with percutaneous MCS is solvedeither by inserting larger intracorporeal pumps surgically or bychoosing an extracorporeal pump, with all the potential problems aredescribed above.

Known mechanical circulatory support systems are life-saving. However,they remain costly, complex and have limited clinical potential with amajority of patients still passing away unaided.

Currently available percutaneous treatments rely on the main structuresof the patient's anatomical vascular structure to be undamaged. However,many heart patients are children with congenital heart defects orelderly patients often with anatomical and vascular anomalies, such ascalcifications and valvular disease. With surgery, such limitations maybe overcome but benefit is hampered by the risk associated with surgicaltrauma. There is therefore a need for a procedure and device that cansafely and predictably be deployed by percutaneously achieving accessfrom one anatomical structure to another as this will allow for safedelivery of more efficient pumps without surgical trauma.

It is an object of this invention to mitigate problems such as thosedescribed above.

SUMMARY OF INVENTION

According to a first aspect of the invention, there is provided atranscatheter system comprising an intracorporeal connector for fluidcommunication between two anatomical compartments through at least oneanatomical wall. More particularly, the connector is adapted to receivean intracorporal flow regulating device.

Within the context of the invention, transcatheter includespercutaneous, trans-atrial, trans-femoral (through the leg),trans-apical (in the chest between the ribs), and trans-aortic (in theupper chest). Preferred embodiments are percutaneous systems, devicesand methods.

The system according to the present invention is a transcatheter systemand there is therefore no need for invasive and traumatic open surgery(as required for example to install a HeartMate™ system). Furthermore,both the connector and the flow regulating device are intracorporeal sothat no major external parts are required. There is no need for completepatient immobilisation, as it is the case with a TandemHeart™ system, inwhich an extracorporeal pump is required. The system can therefore beused for short-, medium- and long term treatment. In addition, byconnecting two anatomical compartments through one or more anatomicalwalls, the system can by-pass defective or anomalous anatomical parts.Rather than fixing or replacing existing problematic anatomical parts,the system according to the present invention effectively creates a newpathway for fluid circulation. This is therefore the basis for a moreforgiving and versatile procedure.

The connector is able to preserve the integrity of the anatomicalstructure and tissues against the pressure exerted by the fluid (blood)flow and the flow regulating device, thereby preventing the collapse ofthe compartment(s).

In a preferred embodiment, when the flow regulating device is coupled tothe connector, fluid can flow from the first compartment to the secondcompartment, and when the flow regulating device is not coupled to theconnector, fluid cannot flow from the first compartment to the secondcompartment. The flow regulator device therefore functions as anactuator for the connector so that in the absence of the flow regulatordevice, fluid cannot flow between the compartments. The connector isinserted via percutaneous or transcatheter insertion, followed by theflow regulating device, also inserted via percutaneous or transcatheterinsertion. Thus, the flow regulating device is coupled to the connectorin situ. This is a marked difference with known systems either using anextracorporeal pump or in which the VAD is assembled outside thepatient's body, then inserted as one bulky device. The present inventionis particularly advantageous in that the intracorporeal assembly allowsthe use of smaller components for a minimally invasive procedure. Inaddition, this procedure is ideal for smaller patients, for example forpaediatric applications. It is also interesting to note that the flowregulating device and/or the connector can be collapsible as will bedescribed below in further detail.

The present invention is particularly advantageous when one or bothcompartments are compartments of the circulatory system. The preferredembodiment concerns a left atrium-aorta procedure. However, othercompartment pairs are envisaged including, but not limited to, rightventricle-aorta, left ventricle-aorta, right atrium-vena cava superior,left atrium-aorta descending, left atrium-aorta ascending, rightventricle-pulmonary artery

The present invention is particularly useful for use in the treatment ofheart failure, diastolic heart failure, systolic heart failure, leftventricle failure, right ventricle failure, paediatric heart anomaliesand/or shunts. Alternatively or additionally, one or both compartmentsare compartments within the thoracic cavity or the abdomen.

Preferably, the at least one anatomical wall is an outer wall of thecompartment. For example, where the treatment is applied to the heart,then the artificial fluid passageway is an extra-cardiac passageway.Within the context of the invention, the expression “extra-cardiacpassageway” means between the inside of the heart and the outside of theheart.

The number of walls through which fluid communication is created dependson the compartments to be connected. For example, a left atrium to aortaconnection involves puncture and fluid communication through twoanatomical walls (i.e. the roof of the left atrium and the aortic wall),whereas a right to left atrium connection only involves one anatomicalwall (i.e. the atrial septum). Fluid communication is establishedthrough internal anatomical walls and not through external walls such asskin tissues. Preferably, the anatomical compartments are separated bytwo anatomical walls. More preferably, the connector connects twoanatomically non-adjacent compartments. This means for example twocompartments in close proximity of each other, but not anatomically indirect contact. This may also include two compartments which are inanatomical contacts in some parts, but are connected with the systemaccording to the present invention at a portion in which the twocompartments are not in anatomical contact. By way of example, the aortaand the left atrium of the heart may be in anatomical contact in someparts, but the connection is made for example through the roof of theleft atrium and the aortic wall, where these two compartments are not inanatomical contact.

Preferably, the connector comprises a neck for fluid passage from onecompartment to the other and means for securing the neck across theanatomical wall. In use, the neck of the connector is preferablyembedded across the anatomical wall(s) and, if applicable, acrossinterstitial space between two anatomical compartments/walls.Preferably, the neck comprises means for securing or detachably securingthe flow regulating device to the connector.

An embodiment of the neck may comprise a channel for fluid passage fromone compartment to the other. Preferably, the fluid channel ispositioned along the central longitudinal axis of the neck. The neckportion is preferably sealed so that there is no fluid lateral leakageinto the anatomical wall(s) and/or into any space separating twoanatomical walls.

The neck can be susceptible to be dislodged, not only from the patient'smovement, but also from the heart beating mechanism itself and it istherefore preferable to include means for securing and/or anchoring theneck across the anatomical wall(s). Thus, the securing means maycomprise an anchor extending from a first end of the neck. The anchormay be expandable. More preferably, in its securing position, the anchorlies substantially parallel to the anatomical wall. In a preferredembodiment, the anchor can extend substantially perpendicularly from afirst end of the neck and lay substantially parallel to the anatomicalwall. Preferably, the anchor will be located in the anatomicalcompartment into which the fluid is delivered. The anchor secures theneck, and therefore the connector, across the anatomical wall(s), butalso assist in preserving the integrity of the anatomical wall(s).

In one embodiment, the (expanded) anchor is substantially in the shapeof a disk. In another embodiment, the anchor comprises a plurality ofdeployable arms. The deployable arms are preferably curved or maycomprise one or more elbows

The connector may also be secured to the anatomical wall(s) for exampleby using a neck made of an expandable material so that the neck isinserted in an unexpanded state, and expands upon release to closelycontact the opening through the anatomical wall(s).

Preferably, the connector comprises means for preventing tissue fromhindering fluid passage through the neck. The fluid passage, inparticular in the case where a pumping device is used, creates a suctionof the surrounding tissues towards the connector neck. The preventionmeans may comprise a shield extending from a second end of the neck. Theshield may be expandable. The shield prevents surrounding tissues frombecoming trapped in the connector neck and from hindering fluid passage.This type of shield can also act as an additional means for securing theconnector neck in its correct position. Preferably, the shield islocated in the anatomical compartment from which the fluid is removed.Preferably, the shield in its expanded state is substantially umbrella-or bowl-shaped. This embodiment is advantageous in that the surroundingtissues do not rub directly against the shield and are not sucked intothe shield, so that scratches and injuries can therefore be avoided.Mesh-type or grid-type materials are preferred so as to minimise theamount of foreign material introduced into the patient. The shieldprevents hindrance from tissues, but also secures the connector throughthe anatomical wall and assists in preserving the integrity of theanatomical wall(s).

In one embodiment, the (expanded) shield is substantially in the shapeof a bowl or umbrella. In another embodiment, the shield comprises aplurality of deployable arms. The deployable arms are preferably curved.

Although a preferred connector is described as comprising one anchor andone shield, connectors comprising one anchor or one shield, two anchorsor two shields are also envisaged.

As explained above, the integrity of the anatomical wall(s) may becomecompromised due to the pressure exerted by fluid/blood flow and the flowregulating device. The system according to the present inventioncomprises means for preserving the integrity of the anatomical wall(s),as embodied for example by the anchor and the shield of the connector.The present invention is particularly valuable when working on fragileanatomical walls, such as the aortic wall. The aortic wall must bemanipulated with the utmost care, as an aortic rupture or anyembolization may have dramatic, if not a lethal, consequences. Thepresent invention provides a method, system and devices which enablesafe puncture, delivery, insertion and implantation.

In a preferred embodiment, the connector is made wholly or partly of ashape memory material. The non-expanded connector can therefore fit intoa sheath for transcatheter introduction into the patient. Preferably,the anchor and/or the shield are made of shape memory material. Theconnector can be introduced in a non-expanded elongated state through adelivery sheath.

Preferably, the neck comprises a gate to selectively prevent or allowpassage of fluid through the neck. In a closed state, the gate preventspassage of fluid from one anatomical compartment to the other. The gatemay be actuated, opened and maintained in an open stated mechanically,for example by using a flow-regulating device as described below.

Preferably, the device comprises means for securing the flow regulatingdevice to the connector. One embodiment of such securing means is a gateas described above, which closes around the neck of the flow regulatingdevice. In another embodiment, the connector and the flow regulatingdevice may comprise complementary securing means, such as screwingmeans, preferably located on the inner surface of the neck of theconnector and on the outer surface of the intermediate portion of theflow regulating device.

In another embodiment, the anchor and/or the shield of the connectorcomprise a plurality of arms. The arms may extend from one or both endsof the neck to form an anchor and/or a shield. The arms may extend alongthe inner surface of the neck to form a screwing means for securing theflow regulating device to the connector.

The screwing means is particularly advantageous in that the flowregulating device can be (detachably) secured to the connector, but canalso be used to assist advancement and positioning of the flowregulating device through the connector.

The connector may comprise means for sealing for preventing undesirablefluid flow at the coupling interface between the connector and the flowregulating device or securing means. In a preferred embodiment, theconnector and the flow regulating device comprises complementaryscrewing means and the sealing means comprises a strip of sealingmaterial mirroring the screwing contour of the screwing means. Thus, inuse, the sealing means is sandwiched between the screwing means of theconnector and the screwing means of flow regulating device.

In a preferred embodiment, the sealing means is expandable. In itsexpanded, the sealing means is in the shape of a substantiallyrectangular strip of sealing material. In its collapsed state, thesealing means is substantially screw shaped. The sealing means may bemade of a flexible material and/or a shape memory material. The sealingmeans may comprise means for securing the sealing means to the connectorand/or the flow regulating device.

In a preferred embodiment, the system further comprises anintracorporeal device for regulating the flow of fluid between the twoanatomical compartments. This flow-regulating device may enable thefluid flow from one compartment to the other to be interrupted orinitiated, or the fluid flow rate to be adjusted. This is particularlyadvantageous because the present system creates fluid communicationthrough an artificial opening through an anatomical wall and there wouldtherefore be no natural existing mechanism to regulate the flow of fluidbetween anatomical compartments. For example, in the circulatory system,blood circulation is regulated by the heart muscles and existing naturalopenings, such as the aortic valve or mitral valves. The presentinvention does not rely on these natural openings and does not seek torepair defective natural openings, but instead create a new artificialblood pathway.

Preferably, the flow regulating device comprises an actuator capable ofallowing or preventing fluid flow through the intracorporeal connector.Thus, fluid communication from one anatomical compartment to the otherthrough the connector can be activated or terminated using the actuator,preferably by opening or closing the gate of the connector neck. In apreferred embodiment, fluid communication is enabled when the flowregulation device is mechanically coupled to the connector device andfluid communication is terminated when the devices are separated fromeach other.

In a preferred embodiment, the flow regulating device comprises a firstportion located in use in the first compartment, a second portionlocated in use in the second compartment, and an intermediate portionlocated in use through the anatomical wall(s).

Preferably, in use (i.e. when the flow regulating device is correctlyimplanted across the anatomical wall(s), the intermediate portion islocated through and secured to the neck of the connector. Morepreferably, in use, the intermediate portion is located through the gateof the connector. In a preferred embodiment, the outer dimensions of theintermediate portion of the flow regulating device is substantiallycomplementary to the inner dimensions of the neck of the connector.

Preferably, the first portion comprises one or more apertures for fluidcommunication between the first and second compartment. Preferably, theintermediate portion comprises a channel for fluid communication betweenthe first and second compartment. Preferably, the second portioncomprises one or more apertures for fluid communication between thefirst and second compartment.

In a preferred embodiment, when the intermediate portion of the flowregulating device is coupled to the connector, fluid can flow from thefirst compartment to the second compartment, and when the intermediateportion of the flow regulating device is not coupled to the connector,fluid cannot flow from the first compartment to the second compartment.

Preferably, the flow regulating device comprises a pump. Thus,parameters such as fluid flow rate and/or timing of fluid flow betweenthe anatomical compartments, and/or volume of fluid can be adjusted.Preferably, the pump is located in the first portion of the flowregulating device.

The system may further comprise means for treating or processing thefluid. In some instances, the fluid, for example blood, may be defectiveor require treatment. If the circulated blood is lacking in oxygen itcan be oxygenated. Means for oxygen delivery can be included in theflow-regulating device, preferably by attaching an external oxygenatorline to the device where oxygen can be released through trans-membranouspassage (membrane-oxygenation) or directly into the blood stream throughmicroscopic openings (bubble-oxygenation).

Furthermore, the blood may be treated by delivering one or more drugcompounds to the fluid or equally, one could envisage means for removinga component (such as a contaminant) of the fluid when it flows throughthe system according to the present invention. Such delivery and removalmeans could be a chemical filter, a membrane and/or one or more openingsin the device attached to an externalised line for substance transport.Advantageously, the intracorporeal device for regulating the flow offluid comprises the fluid treatment means. If required, the system mayalso remove oxygen and/or other gas from the fluid. Other treatmentssuch as heating or cooling of the fluid can also be effected whererequired.

The fluid treatment means may enable the introduction of one or moredrug compounds for treating the fluid or for delivery into one or bothcompartments and/or the introduction of one or more gas, for exampleoxygen. The flow regulating device may include a controller to adjustthe treatment parameters, such as timing, concentrations and dosages. Aslow release or controlled release mechanism for drug delivery is alsoenvisaged.

Preferably, the system comprises means for securing the flow regulatingmeans to the connector. The connector device and/or the flow regulatingdevice may comprise one or more securing means for secured attachment toeach other. The two devices may be detachably or non-detachably securedto each other. This securing means is particularly advantageous whenthere is a risk of the devices becoming accidentally disconnectedbecause of anatomical movement (e.g. from the heart muscles), movementfrom the patient, and/or fluid flow.

In a preferred embodiment, the second portion of the flow regulatingdevice comprises one or more flanges for abutting against the anatomicalwall or the expandable anchor of the connector, thereby securing theflow regulating device to the anatomical wall(s) but also to theconnector.

Preferably, the intermediate portion is made of an expandable materialto closely contact the inner surface of the connector's neck, therebysecuring the flow regulating device to the connector.

In a preferred embodiment, the first portion comprises a cross-sectionof larger diameter than the diameter of the cross-section of theintermediate portion. This feature is advantageous for at least tworeasons. Firstly, the intermediate portion of smaller diameter ispositioned through the anatomical wall(s) and/or the connector and canbe secured into position by the first and second portions. Secondly, thefluid is sucked into the first portion of larger diameter and flowsthrough the intermediate portion of smaller diameter, thereby creating aVenturi effect improving the pumping efficiency of the flow regulatingdevice.

Preferably, the second portion is substantially cone-shaped so as tofacilitate insertion of the flow regulating device into and through theconnector and/or the anatomical wall(s) and to minimize the risk oftrauma. More preferably, the second portion comprises a rounded distaltip for atraumatic insertion.

In a preferred embodiment, the flow regulating device is adapted toreceive a guide wire therethrough. Preferably, the first portion, thesecond portion and/or the intermediate portion comprises an aperture toreceive a guide wire therethrough. Preferably, the flow regulatingdevice is adapted to receive a guide wire along its longitudinal axis.More preferably, the first portion, the second portion and/or theintermediate portion comprises a channel to receive a guide wiretherethrough. Most preferably, the channel is positioned along thelongitudinal axis of the flow regulating device.

In a preferred embodiment, the flow regulating device is collapsible.Preferably, the flow regulating device can be arranged in a firstconfiguration for insertion through a sheath and in a second workingconfiguration. Preferably, the flow regulating device comprises an outercasing. The outer casing is preferably made of a flexible material. Thisis particularly advantageous as it improves the potential size (andtherefore the efficiency) of the pump for transcatheter delivery whichmay also improve the potential for employing transcatheter magneticdrive pumps for long term use.

In a preferred embodiment, the flow regulating device may comprise arotatable shaft supporting at least one blade, said blade being adaptedfor extension in the longitudinal direction of the shaft into aninsertion configuration. The blade is adapted for relaxation in thelongitudinal direction of the shaft into a working configuration.

In the lateral direction of the shaft, the dimension of the blade may begreater in the working configuration than in the insertionconfiguration. Thus, the blade and hence the flow regulating device caneasily be inserted through a sheath.

Preferably, the blade is a screw type blade. The blade may be onecontinuous blade and/or a serpentine type blade. Preferably, the bladeis made of a resilient (memory) material so that the blade can beextended or stretched in the longitudinal direction of the shaft.

The flow regulating device in its insertion configuration may bedelivered to its working position through a delivery sheath or catheter.The flow regulating device expands into its working configuration as itexits the sheath, into its working position across the anatomicalwall(s). In a preferred embodiment, the shaft and blade assembly iscomprised in a compressible or stretchable outer casing of the flowregulating device. The shaft and blade assembly can be stretched in thelongitudinal direction into an insertion configuration so that thelateral dimensions of the blade are reduced.

In another embodiment, the flow regulating device comprises aninverted-screw pump. In this embodiment, screws or blades are formed ona rotatable inner surface of the flow regulating device so that thefluid is suctioned from the first compartment to the second compartment.

Preferably, the flow regulating device is partly or wholly made of amagnetic material. For example, one or more elements of the device (e.g.casing, blade, magnetic bearing, magnetic drive etc) are made of amaterial with magnetic properties.

The present system is particularly advantageous when one or bothanatomical compartments are compartments of the circulatory system.Compartments of the circulatory system include for example the leftatrium, the right atrium, the left ventricle, the right ventricle, theaorta, the pulmonary artery, the vena cava as well as arteries, veinsand other compartments of the peripheral vascular system. Morepreferably, the system according to the present invention creates fluidcommunication between two adjacent compartments.

Preferably, the fluid comprises or is blood, which may be oxygenated ordeoxygenated. The system according to the present invention isadvantageously used as a mechanical support system, preferably as amechanical circulatory support system, such as a ventricular assistdevice.

In another embodiment, the connector and the fluid regulating device areconstructed as a single device.

According to a second aspect of the invention, there is provided anintracorporeal connector as specified in any one of the precedingparagraphs.

According to a third aspect of the invention, there is provided anintracorporeal flow regulating device as specified in any one of thepreceding paragraphs.

In a fourth aspect of the invention, there is provided a transcatheterinsertion device comprising a guide wire comprising an integrally formedpuncture head. The transcatheter insertion device enables the punctureof anatomical structures, for example anatomical wall(s) separatinganatomical compartments, and is particularly advantageous for thepuncture of outer walls of anatomical compartments with greater tissueresistance. The puncture head is preferably shaped so as to present anextremely sharp end to allow the practitioner for improved precision andcontrol in a critical phase of the procedure. Such sharp end wouldnormally not be used because of the risk of accidental puncture and/orinjury. However, in the present invention the transcatheter insertiondevice is configured, as will be explained in further details below, toprevent such accidents.

In addition, the insertion device acts as a guidewire over which thevarious elements of the system according to the present invention, suchas the intracorporeal connector device or the intracorporeal flowregulating device, can be inserted. Thus, it is possible to use a singledevice for both the puncturing step and the insertion/delivery steps ofthe procedure. In conventional methods, the puncture device would beperformed using a separate puncture needle, which would be removed afterpuncture and followed with the introduction of a guide wire. This is notrequired with the present invention. In a known insertion system, ahollow needle is used to puncture the skin. A guide wire is insertedthrough the needle channel and the needle is removed leaving the guidewire in place. A catheter is then passed over the guide wire and thewire is removed, leaving the catheter in place. In the presentinvention, the puncture is made with the distal end of the guide wire,and in particular with the puncture head of the guide wire. This allowsfor a gradual, atraumatic and accurate incision to be made and this isparticularly advantageous when puncturing outer walls of anatomicalcompartments, for example for cardiac to extra-cardiac puncture such asfrom one heart compartment heart into a major blood vessel.

Preferably, the puncture head comprises a solid distal tip. In otherwords, the puncture head is not hollow or does not comprises a distalaperture like in a conventional vascular puncture-needle as this wouldcreate an unnecessarily larger incision and often will require the useof undesired force for successful puncture. Larger incisions are notdesirable where dangerously high blood flows are expected. The use ofconventional needle is not recommended for anatomical wall such as theaortic wall in view of the risk of aortic rupture. In other conventionalmethods, a standard guide wire might be used to perform the puncturestep. However, standard guide wires have a rounded or flat head whichdoes not permit accurate puncture and may be dangerous if theyaccidentally deflect from the anatomical wall to be punctured. Morepreferably, the puncture head comprises a conical distal tip.

In a preferred embodiment, the diameter at the base of the conical tipis substantially the same as the diameter of the guide wire.

In a preferred embodiment, the guide wire is capable of coiling aroundthe puncture head. Preferably, the guide wire comprises a flexibledistal portion adjacent the puncture head, and a more rigid proximalportion. These features are particularly advantageous in the preventionof injuries due to the sharpness of the puncture head. Once the puncturehas been performed, the puncture head advanced into the secondcompartment together with the dilator. When the dilator is removed, theflexible portion of the guide wire becomes unsupported and coils aroundthe anchored puncture head, so as to provide an effective shield betweenthe puncture head and surrounding tissues. More preferably, the guidewire is made of a shape memory material so that the guide wire can beconfigured into a shield surrounding the puncture head.

Preferably, the insertion device further comprises comprising a dilator.More preferably, the dimensions of the widest cross section of thepuncture head are substantially the same as those of the distal end ofthe dilator.

Preferably, the insertion device comprises a delivery sheath. Morepreferably, the insertion device comprises an inner delivery sheath andan outer delivery sheath. In a preferred embodiment, the insertiondevice comprises a guide wire with a puncture head, a dilator, an innerdelivery sheath and an outer delivery sheath.

The insertion device allows the puncture of anatomical walls and theinsertion of a sheath or catheter through the patient's anatomy forsubsequent introduction of transcatheter devices and the insertiondevice may further comprise means for guiding a sheath. The presentinvention is particularly advantageous in procedures involving insertionand implantation through two anatomical walls. This is because theinsertion device can push one wall in contact with the other so thatpuncture and subsequent insertion and implantation are facilitated.

The system may be presented in the form of a kit comprising anintracorporeal connector, an intracorporeal flow regulating deviceand/or a transcatheter insertion device.

According to a fifth aspect of the invention, there is provided atranscatheter method for providing fluid communication between twoanatomical compartments separated by at least one anatomical wall, themethod comprising the steps of (a) puncturing the wall(s) separating thecompartments, (b) inserting an intracorporeal connector through thepuncture(s), and (c) coupling an intracorporeal flow regulating deviceto the intracorporeal connector. Preferably, step (c) is carried outintracorporeally.

Preferably, the puncturing step is carried out using an insertion deviceas specified in any one of the preceding paragraphs.

Preferably, the intracorporeal connector is a connector as specified inany one of the preceding paragraphs.

Preferably, the intracorporeal flow regulating device is a flowregulating device as specified in any one of the preceding paragraphs.

Preferably, the anatomical compartments are separated by two anatomicalwalls. More preferably, the two anatomical compartments are twoanatomically non-adjacent. An advantage of the present invention is thatfluid passage can be effected between two anatomically distinctcompartments through an artificial fluid communication pathway.

Preferably, the method further comprises the step of pushing the twoanatomical wall into contact prior to the puncture step (a) using theinsertion device.

Preferably, the insertion step (b) is carried out using the insertiondevice. The puncture head of the insertion device can be used to performstep (a) to puncture the anatomical wall(s) and the guide wire toperform step (b) during the insertion procedure. Accordingly, in apreferred embodiment, the insertion device comprises a guide wirecomprising an integrally formed puncture head.

Preferably, the method comprises the step of puncturing the wall(s)separating the compartments using the puncture head and guiding theintracorporeal connector through the puncture using the guide wire.

Preferably, the method further comprises the step of inserting andpositioning the flow regulating device into coupling position relativeto the connector.

Preferably, the method comprises the step of guiding the flow regulatingdevice using the guide wire of the insertion device.

In a preferred embodiment, the intracorporeal connector and/or theintracorporeal flow regulating device are inserted in a collapsed state.

Preferably, the method further comprises the step of securing theconnector to the anatomical wall(s).

Preferably, the method further comprises the step of securing the flowregulating device to the connector.

Preferably, the method further comprises the step of preventing tissuefrom hindering fluid passage through the flow regulating device.

Preferably, the method further comprises the step of regulating the flowof fluid by means of a pump comprised in the flow regulating device.

Preferably, the method further comprises the step of treating the fluid.In a preferred embodiment, the treatment of the fluid is carried outusing the treatment means as specified above comprising the step ofcontacting the fluid with one or more drug compounds. Preferably, themethod comprises the step of contacting the fluid with one or more gas,such as oxygen.

In a preferred embodiment, the method further comprises the step ofdetaching and retrieving the flow regulating device from the connector.The present invention is ideal for permanent or semi-permanentapplications. However, in some circumstances, the flow regulating devicemay need to be retrieved for example for replacement and/or repair.

Preferably, the step of detaching and retrieving the flow regulationdevice is carried out using a retrieval device. More preferably, theretrieval device comprises means for grabbing the flow regulatingdevice.

Preferably, one or both compartments are compartments of the circulatorysystem. More preferably, one of the compartments is the left atrium ofthe heart and/or one of the compartments is the aorta. Most preferably,the anatomical walls are the roof of the left atrium and the aorticwall.

According to a sixth aspect of the invention, there is provided a methodfor inserting a transcatheter system, comprising the step of puncturingat least one anatomical wall separating two anatomical compartmentsusing an insertion device as described above.

Preferably, the anatomical compartments are separated by two anatomicalwalls. More preferably, the two anatomical compartments are twoanatomically non-adjacent.

Preferably, the puncture method comprises the step of inserting theinsertion device into the patient's circulatory system until thepuncture head abuts the anatomical wall to be punctured.

Preferably, the puncture method comprises the step of pushing the twoanatomical compartments into contact with each other using the insertiondevice.

Preferably, the puncture method comprises the step of puncturing thewall(s) separating the compartments using the puncture head and guidinga percutanous device(s) through the puncture using the guide wire.

Preferably, the puncture method comprises the step of preventing thepuncture head from causing trauma to the patient's anatomy.

Preferably, the puncture method comprises the system is inserted throughthe femoral artery and/or inferior vena cava.

Preferably, one of the compartments is the left atrium of the heartand/or one of the compartments is the aorta. More preferably, theanatomical walls are the roof of the left atrium and the aortic wall.

According to a seventh aspect of the invention, there is provided adevice for coupling or uncoupling the flow regulating device to or fromthe connector. The (un)coupling device comprises means for detachablycoupling with the flow regulating device. Thus, the (un)coupling devicecan grab the flow regulating device for coupling or uncoupling and forimplantation or retrieval of the flow regulating device. Preferably, thecoupling means comprises one or more tabs capable of engaging with theflow regulating device.

Preferably, the (un)coupling device comprises means for remotelycontrolling the coupling means so the (un)coupling device can beremotely controlled to selectively grab or release the flow regulatingdevice. Preferably, the coupling means is capable of rotation, so thatit can be remotely controlled to selectively screw or unscrew the flowregulating device from the connector.

Preferably, the (un)coupling device comprises a catheter and a distalcoupling means. Preferably, the catheter comprises one or more elbows sothat the catheter can be advanced through the patient's anatomy withoutkinking.

The system and devices according to the present invention areparticularly advantageous when used for the treatment of heart failure,diastolic heart failure, systolic heat failure, left ventricle failure,right ventricle failure, paediatric heart anomalies and/or shunts.

The present invention also concerns a transcatheter method for creatingan artificial communication between two separate compartments through ananatomical wall (as opposed to a natural existing anatomical opening)comprising the step of using the transcatheter insertion device asdescribed above, a transcatheter method for treating and/or processing afluid comprising the step of using a flow regulating device as describedabove, a method for inserting an intracorporeal connector as describedabove, a method for inserting an intracorporeal flow regulation deviceas described above. Other methods relating to the present invention willbe described below by way of example.

Within the context of the invention, the term “percutaneous” is usedwith reference to any medical procedure where access to inner organs orother tissue is done through a puncture and/or incision through the skin(and/or the vascular system) for example into the circulatory system, asopposed to an open surgery procedure. Thus, a percutaneous methodinvolves the percutaneous delivery of elements and may involve anincision (for example with a scalpel) to enable percutaneous delivery.In a preferred embodiment, the method provides transcardiovasculardelivery of one or more devices for establishing fluid communicationbetween anatomically separate but adjacent thoracic organs, aftergaining access to the vascular system by a puncture or incision. Thepuncture or incision may be made at various sites where intravascularaccess is possible, for example in the groin, axilla, chest or abdomen.

BRIEF DESCRIPTION OF DRAWINGS

The invention will be further described with reference to the drawingsand figures, in which:

FIG. 1 is a schematic representation of an intracorporeal connector anda flow regulating device according to the present invention;

FIGS. 2A to 2C are schematic representations of an intracorporealconnector according to the present invention;

FIGS. 3A and 3B are schematic representations of gates for anintracorporeal connector according to the present invention;

FIGS. 4A and 4B are schematic representations of a flow regulatingdevice according to the present invention;

FIGS. 5A to 5C are schematic representations of an intracorporealconnector according to the present invention;

FIGS. 6A to 6C are schematic representations of a percutaneous insertiondevice according to the present invention;

FIGS. 7A to 7C are schematic representations of a percutaneous insertiondevice according to the present invention;

FIG. 7D is a schematic representation of a percutaneous insertion deviceaccording to the present invention in a substantially straightconfiguration and in a coiled configuration;

FIGS. 8A to 8J are schematic representations of the puncture, insertionand positioning steps of the methods according to the present invention;

FIG. 9 is an illustration of an insertion route in a method according tothe present invention;

FIGS. 10A and 10B are schematic representations of an intracorporealconnector according to the present invention in a compressed state;

FIG. 11 is a schematic representation of an intracorporeal connectoraccording to the present invention in situ;

FIG. 12 is an illustration of a flow regulating device according to thepresent invention during the insertion process;

FIG. 13 is a schematic representation of a system according to thepresent invention in situ;

FIGS. 14 and 15 are schematic representations of a first preferred flowregulating device according to the present invention in an insertedstate;

FIG. 16 is a schematic representation of a second preferred compressibleflow regulating device according to the present invention in an insertedstate;

FIG. 17 is a partial schematic representation of a compressible flowregulating device as shown in FIG. 15;

FIG. 18 is a schematic representation of the compressible flowregulating device as shown in FIG. 16 during insertion;

FIG. 19 is a partial schematic representation of the compressible flowregulating device as shown in FIG. 18;

FIG. 20A is a schematic representation of a first sealing element foruse in the present invention, in an expanded position and in twoalternative working positions;

FIG. 20B is a schematic representation of a second sealing element foruse in the present invention;

FIGS. 21A to 21D are top and bottom views of connector according to thepresent invention with an anchor and a shield comprising a plurality ofarms;

FIG. 21E is a partial schematic representation of a connector accordingto the present invention;

FIG. 22 is a schematic representation of an flow regulating deviceaccording to the present invention comprising an inverted screw pump;

FIG. 23 is a schematic representation of a (un)coupling device accordingto the present invention.

DETAILED DESCRIPTION

Referring to FIG. 1, there is illustrated a percutaneous system 1, insitu, comprising an intracorporeal connector 2 for fluid communicationbetween two anatomical compartments 3,4 through at least one wall 5,6.In this illustration the first compartment is the left atrium 3 of theheart, the second compartment is the aorta 4, a first anatomical wall isthe roof 5 of the left atrium 3 and a second wall is the wall 6 of theaorta 6.

The connector 2 is designed to preserve and support the structuralintegrity of the anatomical walls and compartments generally against thepressure exerted by the flood flow, but also during the insertion,implantation and retrieval processes of percutaneous devices.

An intracorporeal connector 2 according to the present invention will bedescribed with reference to FIGS. 1 and 2A to 2C. The connector 2comprises a waist or neck 7, and anchor 8 and a shield 9. Fluid, in thiscase blood, can flow across the neck 7 through a gate 10. The connector2 is made of one or more biocompatible material and, if required, can beleft in the patient after the treatment is completed.

The neck 7 is typically made of a semi-flexible to substantially rigidmaterial so that the pressure from the surrounding tissues does notcompress the neck 7 and prevent fluid flow. The neck 7 comprises abiocompatible or surgical material, such as a metal or plastic material.The gate 10 is made of a resilient material (such as a plastic materialor shape memory material) so that it can be in an open position allowingfluid flow or a closed position preventing fluid flow. The neck 7 maycomprise a solid surface as shown in FIGS. 1 to 3A and 3B or may be madeof a mesh-type surface as shown in FIG. 21E.

The gate 10 retains a closed position in the absence of action from anactuator. Two examples of gate 10 are shown in FIGS. 3A and 3B. In FIG.3A, the gate 10 is made of several portions which can fit together in aclosed position and can be pushed apart to create an opening. In FIG.3B, the gate 10 comprises an opening 10A which prevents blood flow in aclosed position, but can be stretched into an open position to allowblood flow.

In this embodiment, the system 1 connects the left atrium 3 to the aorta4, which are relatively close to each other. However, where thecompartments are oddly positioned or further from each other, thedimensions and shape of the neck 7 can be modified. For example, theneck 7 may be flexible enough to bend into a suitable position orarticulated.

The anchor 8 extends from a first end of the neck 7. The anchor 8 ismade of a resilient material, such as a shape memory material, so thatit can be inserted in a folded state, as shown in FIGS. 10A and 10B andinstalled in an expanded state, as shown in FIGS. 1 and 2. In its foldedstate, the anchor 8 has a substantially cylindrical shape. In itsexpanded state, the anchor 8 can be deployed to prevent the connector 2from moving within or being dislodged from the anatomical walls 5,6. Inthis embodiment, the anchor 8 in its expanded state is attached to andextends substantially perpendicularly from the end of the neck 7 so thatit lies against and/or substantially parallel to the anatomical wall,here the aortic wall 6.

The shield 9 extends from the second end of the neck 7. The shield 9 ismade of a resilient material, such as a shape memory material, so thatit can be inserted in a folded state, as shown in FIGS. 10A and 10B andinstalled in an expanded state, as shown in FIGS. 1 and 2. The shield 9comprises a mesh-type or grid-type material and can be made of the samematerial or a different material than that of the anchor 8. In itsfolded state, the shield 9 has a substantially cylindrical shape. In itsexpanded state, the shield 9 can be deployed to prevent surroundingtissues from being sucked towards and/or into the puncture through theanatomical walls 5,6. The shield 9 expands so that the surroundingtissues are not contacting the shield. This minimises the risk of injurydue to suction through the mesh or rubbing against the shield. In thisembodiment, the shield 9 expands into a substantially bowl-shape orumbrella-shape.

In the FIGS. 1 to 3A and 3B, the anchor 8 is disk-shaped and the shield9 is bowl-shaped. Both are made of a mesh-type material. In anadditional or alternative embodiment, the connector 2 comprises aplurality of arms extending from one end or both ends of the connector 2to form an anchor 8 and/or a shield 9. The arms may be curved and/orcomprise one or more elbows and may be deployable or not. The arms mayextend along the inner surface of the neck 7 to form a screwing meansfor securing the flow regulating device 11 to the connector 2. Examplesof such connectors are shown in FIGS. 21A to 21 E.

A flow regulating device 11 according to the present invention will nowbe described with reference to FIGS. 4 and 5.

The device 11 comprises distal portion 11A, an intermediate portion 11Band a proximal portion 11C. In use, the distal end or tip of the distalportion 11A extends into one anatomical compartment 4 and the proximalend or tip of the proximal portion 11C extends into the secondanatomical compartment. The intermediary portion 11C sits partially orcompletely in the neck 7 of the connector 2. Within the context of theinvention, the term “distal” refers to the position closest to thepatient and the term “proximal” to the position closest to the medicalpractitioner in the direction of insertion. In other words, the distalend of a device is inserted first and its proximal end is inserted last.

The device 11 comprises a channel (now shown) for blood passage throughfrom the proximal portion 11C to the distal portion 11A of the device11. The proximal end comprises one or more openings 12 to allow blood toenter the device 11, and the distal end comprises one or more openings13 to allow blood to exit the device 11. The distal end of the device 11is rounded to minimise trauma and pointed for ease of insertion.

The flow regulating device 11 comprises means for securing the device 11to the connector 2 and examples of such securing means are illustratedin FIGS. 5A to 5B. In FIG. 5A, the distal portion of the device 11comprises one or more ribs 14 or tabs which prevent the device 11 frommoving against the flow of fluid. In FIG. 5B, the intermediary portion11B is partially or wholly made of a resilient or expandable material,which maintains the device 11 in place. The outer surface of theintermediary portion 11B can be modified so that it provides a bettergrip onto the connector neck's inner surface. In FIG. 5C, the distalportion 11A of the device 11 comprises flaps 15 or tabs which can beexpanded to prevent the device 11 from moving against the flow of fluidor folded during the insertion procedure.

Another example of securing means is embodied by the gate 10. During theinsertion procedure, the distal tip of the device 11 is pushed throughand opens the gate 10, and, in its inserted position, the intermediaryportion 11C sits partially or completely in the neck 7 of the connector2, through the gate 10. Thus, the gate material resiliently closesaround the distal portion 11B of the device 11 and secure the device 11to the connector 2. In this description of the insertion procedure, thedistal portion 11A or distal end of the distal portion 11A of the device11 acts as an actuator to the connector 2, by opening the gate 10 andallowing blood to flow from the left atrium to the aorta.

Alternatively, or additionally, the connector 2 and the flow regulatingdevice 11 can comprise complementary securing means, such as screwingmeans, located on the inner surface of the neck 7 of the connector 2 andon the outer surface of the intermediate portion 11B of the flowregulating device 11. The screwing means is particularly advantageous inthat the flow regulating device can be (detachably) secured to theconnector, but can also be used to assist advancement and positioning ofthe flow regulating device through the connector.

In another preferred embodiment, the connector 2 and the flow regulatingdevice 11 can be coupled by means of a twist and lock mechanism, anexample of which is shown on FIG. 21E. In this embodiment, the neck 7may comprise two or more channels or longitudinal protrusions forlocking.

The connector 2 can also comprise means for sealing for preventingundesirable fluid flow at the coupling interface between the connectorand the flow regulating device or securing means. For example, theconnector and the flow regulating device comprises complementaryscrewing means and the sealing means comprises a strip of sealingmaterial mirroring the screwing contour of the screwing means. Thus, inuse, the sealing means is sandwiched between the screwing means of theconnector and the screwing means of flow regulating device.

An expandable sealing means can be used, which in its expandedconfiguration, is in the shape of a substantially rectangular strip ofsealing material. In its collapsed state, the sealing means issubstantially screw shaped. The sealing means can be made of a flexiblematerial and/or a shape memory material. The sealing means may comprisemeans for securing the sealing means to the connector and/or the flowregulating device.

The flow regulating device 11 comprises a channel 34 through which theguide wire 19 b is received. In a preferred embodiment, the channel 34extends from the proximal end to the distal end of the flow regulatingdevice 11. Preferably, the channel 34 extends along the centrallongitudinal axis of the flow regulating device 11.

The flow regulating device 11 comprises an internal pump 16. The pumpingparameters can be adjusted by an intracorporeal or extracorporealcontroller (not shown). In the case of an extracorporeal controller,wireless control is preferred. Current can be fed to the pump 16 throughan electrical lead 17 or the device 11 can contain an internal battery.In the case of a chargeable battery, charging mechanisms which do noinvolve the insertion of further devices into the patient are preferred,for example, a magnetic charging mechanism. If the battery cannot berecharged, then the device 11 can be removed and replaced or discardedafter use. The electrical lead 17 or other tubing may be used as a pullstring to remove the device 11 from the patient after use or a dedicatedpull string may be added.

If the fluid pumped from one compartment 3 requires treatment orprocessing before being delivered into the second compartment 4,suitable means (not shown) can be incorporated into the device 11. Forexample, a drug delivery device can contact the blood flowing throughthe device 11 with one or more drugs; or the blood can be oxygenatedbefore exiting the device 11 using an oxygenating device or membrane. Inthe case of drug delivery, the device 11 incorporates a drug reservoiror be connected to an external drug reservoir. A slow- orcontrolled-release mechanism is also envisaged. The system 1 accordingto the present invention could also be regarded as an intracorporealdrug delivery system, in which a drug is delivered into a targetcompartment, with or without blood flow.

The flow regulating device 11 is self contained so that all theelements, including the pump 16, drug delivery or oxygenation devices,as required, are incorporated in the casing of the flow regulatingdevice 11.

A preferred flow regulating device 11 for use in the present inventionis described with reference to FIGS. 16 to 19. This device 11 is avariation of the device as described above and can comprise any featurerelating to the device 11 as described in the preceding paragraphs.

The flow regulating device 11 comprises a distal portion 11A, anintermediate portion 11B and a proximal portion 11C. The proximalportion 11C forms a casing partially or wholly surrounding the pump 16.The proximal portion 11C further comprises a detachable base 11D. Thebase 11D can be attached by rotation, for example by screw or bayonetmeans. This detachable base 11D comprises one or more openings 27 sothat fluid can flow into the base openings 27 from a first anatomicalcompartment, through the device 11 and exit through openings 13 at thedistal portion 11A of the device 11 into a second anatomicalcompartment.

The base 11D comprises a rotatable shaft 16A supporting at least oneblade 16B. The blade 16B is a screw type blade extending from the shaft16A. The proximal end of the blade may be extend from the shaft 16A. Thedistal end of the blade 16B may be attached or not to the distal end ofthe proximal portion 11C of the device 11 or the proximal end of theintermediate portion 11B of the device 11. The screw blade 16B isarranged and constructed such that it can be extended or stretched inthe longitudinal direction of the shaft 16A for ease of insertionthrough a working sheath 21. In this extended configuration, the screwblade 16B is stretched longitudinally so that the overall diameter ofthe blade 16B is smaller than in the relaxed configuration. The blade16B reverts to its original relaxed configuration, i.e. its workingconfiguration, as it exits the sheath 21. In its working configuration,the overall diameter of the blade 16B is greater than in the stretchedposition. Thus, in the stretched configuration, the screw blade 16B caneasily be inserted through a sheath 21 and in the working configuration,the size of the blade 16B is maximised for optimum capacity andefficiency. This also means that a blade 16B with a greater number ofthread forms per unit length (and therefore greater efficiency) can beused. Any part of the device 11, in particular, the proximal portion 11Cof the device 11 and/or blade 16B, can be made of a resilient (or shapememory) material, which may be the same or different. In a preferredembodiment, the extendable pump is surrounded by a proximal portion 11Cof the device 11, and the proximal portion 11C is made of a resilientmaterial such that it can be compressed to fit into a sheath andsubsequently deployed use. In this embodiment, the base 11D ispreferably made of a rigid material.

In another embodiment as shown in FIG. 22, the flow regulating device 11comprises an inverted-screw pump mechanism in which screws and/or blades33 are formed on a rotatable inner surface of the flow regulating device11 so that the fluid is suctioned from the first compartment to thesecond compartment. In this embodiment, blood flows centrally within theflow regulating device. This arrangement is also advantageous in thatthe/a guide wire can easily be positioned along the central longitudinalaxis of the flow regulating device 11.

The base 11D can comprise a compartment (not shown) for including a pumpmotor, other elements required for the pump to function, fluid treatmentand/or processing means as described above. Alternatively, the base 11Dor proximal portion 11C may comprise one or more ridges for drug and/oroxygen delivery. The ridges can for example be disposed around the shaft16A. Any connection 17 between the device 11 and outside the patient'sbody can be attached to the base 11D.

The principle of deployable percutaneous elements, such as expandableconnectors and flow regulating devices, by-passes the current need forminiaturisation. In other words, instead of reducing the size (andtherefore compromising capacity and efficiency) of the elements, fullsize elements can be inserted into the patient's vascular system throughsmall incisions in a folded or compressed state, deployed at the correctlocation and subsequently removed from the patient in a folded orcompressed state. This paves the way for a more versatile system interms of size and shapes and children in particular would benefitgreatly. This also means that, not only subcutaneous drivelines (similarto those used in connection with pacemakers) can be used, but alsoexternal drivelines and deployable elements can be inserted through thevenous system. Thus, if major arteries can be avoided, the risk ofinfection and heavy bleeding is minimised.

A percutaneous insertion device 18 according to the present inventionwill now be described with reference to FIGS. 6 to 8.

The percutaneous insertion device 18 comprises a puncture head 19 aintegrally formed with a guide wire 19 b and a dilator 19 c. Theinsertion device further comprises a working sheath 21 an outer sheath23. The insertion device 18 is used to insert any device or elementwhich may be required for the method according to the present invention.As will be described in more detail below, the needle 19 and inparticular the puncture head 19 a is used to puncture one or moreanatomical walls; the guide wire 19 b to direct the elements duringinsertion; the dilator 19 c to stretch punctures made by the puncturehead 19 a; the working sheath 21 to insert, deliver and position thedevices of the system 1 and the outer sheath 23 to form a safepassageway for inserting the devices of the system 1.

In this embodiment, the puncture head 19 a is connected to the distalend of the guide wire 19 b for example by welding. The puncture head 19a has a solid tip, i.e. devoid of a hollow channel as observed instandard insertion or injection needles. The puncture head 19 a isconically shaped and forms an extremely sharp tip. The diameter at thebase of the conical puncture head 19 a is larger than that of the guidewire 19 b. The guide wire 19 a is slidable through a dilator 19 c. Thediameter at the base of the conical puncture head 19 a is substantiallyequal to that of the distal end of the dilator 19 c so as to create aflush, smooth transition.

In an alternative embodiment (not shown), the diameter at the base ofthe conical puncture head 19 a is substantially the same as that of theguide wire 19 b so that the guide wire 19 b is a tapered guide wire witha sharp conical tip. In this alternative embodiment, the puncture head19 a and the guide wire 19 b are integrally formed. A diameter of theguide wire 19 b is substantially equal to that of the distal end of thedilator so as to create a flush, smooth transition; although in thiscase, the dilator 19 c may not be required as the tapered guide wire 19b can act as a needle.

The use of a sharp puncture head 19 a at the distal end of the guidewire 19 b allows the insertion device 18 to act as an atraumatic andaccurate puncture device. These relative dimensions of the puncture head19 a, the guide wire 19 b and the dilator 19 c enable the size of thepuncture to be gradually and gently increased.

The guide wire 19 b preferably comprises two or three sections ofdifferent rigidity, for example a distal portion of relatively rigidmaterial, an intermediate portion of flexible material and a proximalportion of relatively rigid material. These differences in rigidityenable the manipulation and guiding of the guide wire through thepatient's anatomy.

With reference to FIG. 7D, the guide wire 19 a comprises at least twosections of different rigidity, namely a proximal portion of relativelyrigid material to guide and push the puncture head 19 a through thepatient's anatomy and a distal portion of more flexible material. Theflexible portion is particularly useful to prevent injury to thepatient's anatomy for example, when advancing the guide wire 19 b orduring the step of inserting and position the intracorporeal devices.For example, the flexible portion can coil around the puncture head 19 ato protect surrounding tissues and to prevent accidental movement of thepuncture head 19 a.

As will be described below in more details, the insertion element 18enables the creation of a safe pathway for the insertion, installationand removal of the various elements of the system 1. More specifically,the insertion device 18 according to the present invention isparticularly advantageous for the puncture of an anatomical wall, suchas an outer wall of an anatomical compartment which has a greater tissueresistance. The insertions device 18 also enables a particularlyaccurate and small incision to be created, which is crucial in incisionsinvolving high pressure blood flow. A preferred use of the insertionelement 18 is for the puncture of outer walls of internal organs, forexample for an extra-cardiac puncture.

A method according to the present invention will now be described by wayof example with reference to a left atrium-aorta connection.

The first step is the insertion of a guide wire, which can be carriedout by means known in the art. A needle carrying a guide wire is placedon the groin area of the patient, adjacent the femoral artery. Pressureis applied so that the patient's skin is punctured by the tip of theneedle and pushed through the skin and tissues into the femoral artery.Once in place, the guide wire is advanced along the femoral artery andup the inferior vena cava 25. With reference to FIG. 9, the guide wireexists the inferior vena cava 25 and enters the right atrium 26. Theseptal puncture between the right and left atrium can also be carriedout by means known in the art. A guide wire now extends from outside thepatient, into the femoral artery through the skin puncture, the inferiorvena cava 25, the right atrium 26, the atrial septum and the left atrium3 lodged preferably in superior left pulmonary vein. Next, a large andsteerable support sheath can be deployed into the left atrium over thewire to facilitate the final steps of the procedure. The skin punctureand/or septal puncture could equally be carried out using the insertiondevice 18 according to the present invention, although the insertiondevice 18 is most advantageous when performing an extra cardiac punctureas described below.

The second step is insertion and installation of the insertion device 18according to the present invention. The needle 19 is inserted throughthe groin preferably through dedicated sheaths 21 and 23 and advancedalong the same path as described above. The guide wire 19 b comprises arelatively flexible (distal) portion adjacent to the puncture headbefore a more rigid proximal portion, so that as the guide wire 19 bfolds upon itself at the flexible portion, thereby forming a U-shape.The flexible portion now advances first, followed by the rigid proximalportion. Thus, the guide wire 19 b can be moved atraumatically throughthe delivery sheath or alternatively, through the patient's bloodvessels. The guide wire 19 b can be straightened when required by gentlypulling the proximal end and repositioning the distal portion at itsfront most position. The puncture head 19 a is pulled back towards thedistal end of the dilator 19 c.

The third step is the extra-cardiac puncture of the left atrium using aninsertion device 18 according to the present invention. The distal endof the outer sheath 23 is placed against the roof of the left atrium 3and pushed against the wall so that the roof of the left atrium 3contacts the aortic wall. The puncture head is advanced so as topuncture the roof of the left atrium 3. This sharp, conical shapeenables the medical professional to create a small and accurateextra-cardiac incision in a smooth and atraumatic manner. The puncturehead 19 a and dilator 19 c are advanced through the puncture towards theaortic wall. The outer sheath 23 is used to push the wall of the leftatrium against the aortic wall and hold both walls together to assistpuncture of the aortic wall. Once the aortic wall is pierced, thedilator 20 can stretch both punctures to facilitate the insertion of theworking sheath 21. The dilator 19 c can be removed to leave the guidewire 19 b and working sheath 21 in place in the aorta 4. The outersheath 23 can remain in the left atrium 3.

The puncture head 19 a is advanced further into the aorta 4. As it exitsthe dilator 19 c, the flexible portion of the guide wire 19 b will coilaround the puncture head 19 a, thereby anchoring and shielding thepuncture head 19 a from surrounding tissues. Additionally oralternatively, a receiving catheter may be positioned into the aorta 4by means known in the art, to receive and protect the puncture head 19 ain the aorta.

It can therefore be seen that the support sheath 23 can be used tosafely deliver the intracorporeal devices but also assists the punctureof the anatomical wall(s), in particular when the procedure involves thepuncture of more than one anatomical wall.

The fourth step is the insertion of an intracorporeal connector 2according to the present invention. With reference to FIGS. 10A and 10B,the intracorporeal connector 2 is inserted in a folded or compressedstate into working sheath 21 along the guide wire 19 b. When theconnector 2 reaches the roof of the left atrium, it is pushed along theguide wire 19 b, through the incision in the anatomical walls 5,6 untilthe neck 7 is correctly positioned across the anatomical walls 5,6 andthe anchor 8 and shield 9 are deployed on either side of the walls 5, 6,in the aorta 4 and the left atrium 3, respectively (FIG. 11). Theconnector 2 gradually expands at it exits the distal end of the workingsheath 21.

The fifth step is the insertion of an intracorporeal flow regulatingdevice 11 as shown in FIG. 4 or 15 according to the present invention.With reference to FIG. 12, the intracorporeal flow regulating device 11is inserted and advanced through the sheath 21 and along the guide wire19 b until it reaches the connector 2. The distal portion 11A and moreparticularly the distal tip of the connector 2 acts as an actuator whichopens the gate 10 in the neck 7 of the connector 7 by stretching theopening 10A of the gate 10. The intermediate portion 11B of the flowregulating device 11 sits in the neck 7 of the connector 2 and issecurely positioned. The flow regulating device 11 can be secured due tothe pressure of the resilient material of the gate 10 and by ribs 14.Additionally or alternatively, the flow regulating device 11 can besecured by screwing the intermediate portion 11B of the flow regulatingdevice 11 to the neck 7 of the connector 2. This screwing mechanism alsoenables the safe and guided advancement of the flow regulating device 11into the connector 2. Where provided, sealing means prevent any leakagethrough the coupling interface between the flow regulating device 11 andthe connector 2. Unless further required, the working sheath 21 can nowbe removed.

It can therefore be seen that the insertion device 18 according to thepresent invention serves a dual purpose. Firstly, the puncture head 19 acan be used in puncturing the anatomical wall(s) in a safe, controlledand atraumatic manner. Secondly, the insertion device 18 can used as anintegrated guide wire 19 b. There is therefore no need for a needle anda separate guide wire to be used in two separate steps. This minimisesthe risk of accidents and injuries and simplifies the insertionprocedure.

In the case of a compressible/expandable flow regulating device as shownin FIGS. 16 to 19, the base 11D of device 11 is detached from theproximal portion 11C and the blade 16B is stretched to its extendedposition. For example, the base 11D is rotated or unscrewed so thatsimultaneously, the base 11D is detached from proximal portion 11C andthe blade 16B is extended. The device 11 is advanced to the distal endof the sheath 21 and the distal portion 11A of the device 11 suitablypositioned ready to actuate gate 10. The base 11D is re-attached to theproximal portion 11C of the device 11, for example by rotating ofscrewing, so that the blade 16B relaxes into its working configuration.The distal portion 11A of the flow regulating device 11 can now bepushed through the gate 10 to allow fluid flow.

The insertion and installation procedures described above can befacilitated by visualisation techniques such as X-ray, fluoroscopy,echocardiography, ultrasound techniques.

The pump 16 is started and blood flow between the left atrium 3 and theaorta 4 can be adjusted. The blood flows from the left atrium 3 into theproximal end of the device 11, through the device and exits through theapertures 13 at the distal end of the device 11 into the aorta 4. Bloodflow, timing of blood flow, temperature and other parameters can becontrolled and adjusted. Similarly, drugs and/or oxygen can be addedand/or contaminants removed from the blood as it passes through thedevice 11. As the blood is sucked into the device 11, surroundingtissues are prevented from hindering the blood passage by the shield 9.The blood flow has a tendency of pushing the device 11 backwards intothe left atrium but the device 11 is immobilised by the securing meansas described above.

The flow regulating device 11 may be removed from the patient when thetreatment is completed, if charging, repair or replacement is required.A sheath 21, 23 is inserted through the patient's anatomy and adedicated (un)coupling device 35 is used which comprising means forcoupling with the flow regulating device 11. The (un)coupling deviceattaches to the flow regulating device 11 for example by means of one ormore engaging tabs 36 a engaging into corresponding recesses 36 b in theflow regulating device 11. The attachment means is remotelycontrollable. The (un)coupling device comprises a rotation means forunscrewing the flow regulating device 11 from the connector 2 and theflow regulating device 11 can be safely retrieved through the sheath21,23. The (un)coupling device may also be used in the insertion processto advance the flow regulating device 11 through the sheaths 21,23 andto screw the flow regulating device 11 to the connector 2.

Upon removing the device 11, the gate 11 closes and blood flow is haltedand the connector 2 can remain in place or be removed.

Although the present invention has been described with respect to a leftatrium to aorta procedure, the system and method can also be applied toother delivery sites including, but not limited to, right atrium-aorta,vena cava-pulmonary artery, vena cava-aorta. Thus, the present inventioncan be broadly applied for example as left ventricular assist devices(LVAD), right ventricular assist devices (RVAD) or biventricular assistdevices (BiVAD), for cardiopulmonary support (CPS) or forintra-corporeal membrane oxygenation (ICMO) or bubble oxygenation, forthe treatment of other organs with pressure issues (e.g. gastric orneurological procedures). The present invention is versatile and a widevariety of applications can therefore be envisaged.

From the above description, it can be seen that the present inventionconstitutes a novel alternative to existing percutaneous procedures. Thepresent percutaneous procedure requires limited mechanical apparatus anddevices and offers a simple as well as safer and cheaper alternative toexisting procedures. All the elements are inserted and implantedpercutaneously so that there is no need for invasive and traumatic opensurgery. Furthermore, the devices described herein can be easily beapplied to paediatric treatments.

It is important to note that the present invention relies on anartificially created fluid pathway. Cardiopulmonary or circulatorycollapse and heart failure can be the result of a variety of acquired ornatural conditions and can affect different anatomical parts of theheart and circulatory and respiratory system. Existing procedures oftenseek to repair or replace the existing defective anatomical parts. Thepresent invention provides a procedure which is more forgiving in thatit relies on artificially created pathways which can by-pass thedefective portion of the circulatory system and allow for use of noveltreatment principles and technologies compared with current treatments.

It is nonetheless envisaged to use the present invention in cases wherethe fluid flow through a natural pathway is insufficient, deficient orunregulated and where it becomes necessary to restore a pathway or afluid flow. This is for example the case with severe pulmonary stenosis,severe aortic stenosis, atresia, and severe MV stenosis.

The present invention allows the safe and atraumatic puncture ofstructurally sensitive anatomical walls by using an insertion devicecomprising a guide wire and an integral puncture head as describedabove. The present invention allows the safe implantation, positioningand working of flow regulating devices using a connector as describedabove, which preserves the integrity of structurally sensitive walls.The present invention allows the treatment of vulnerable patients whomay have anatomical deficiencies which prevent them from being treatedwith conventional methods. The present invention allows the treatment ofsmaller patients, such as children, or where it is not possible to useor introduce bulky devices. The present invention provides a minimallyinvasive procedure which does not compromise the patient'spost-procedure mobility.

This system is a safe, stable and predictable structure for the deliveryof improved therapeutic instruments from one compartment to another,through shorter and more beneficial routes.

Further aspect of the invention can be found in the followingparagraphs.

1. A percutaneous system comprising an intracorporeal connector forfluid communication between two anatomical compartments through at leastone anatomical wall.

2. The system according to paragraph 1, wherein the connector comprisesa neck for fluid passage from one compartment to the other and means forsecuring the neck across the anatomical wall.

3. The system according to paragraph 2, wherein the securing meanscomprises an expandable anchor extending from a first end of the neck.

4. The system according to paragraph 3, wherein, in its expanded state,the anchor lies substantially parallel to the anatomical wall.

5. The system according to any one of paragraphs 2 to 4, wherein theconnector comprises means for preventing tissue from hindering fluidpassage through the neck.

6. The system according to paragraph 5, wherein the prevention meanscomprises an expandable shield extending from a second end of the neck.

7. The system according to paragraph 6, wherein the shield in itsexpanded state does not substantially contact the anatomical wall.

8. The system according to any preceding paragraph, wherein theconnector is made wholly or partly of a shape memory material.

9. The system according to any one of paragraphs 2 to 8, wherein theneck comprises a gate to selectively prevent or allow passage of fluidthrough the neck.

10. The system according to any preceding paragraph, further comprisingan intracorporeal device for regulating the flow of fluid between thetwo anatomical compartments.

11. The system according to paragraph 10, wherein the flow regulatingdevice comprises an actuator to allow or prevent fluid flow through theintracorporeal connector.

12. The system according to paragraphs 11 or 12, wherein the flowregulating device comprises a pump.

13. The system according to any preceding paragraph, further comprisingmeans for treating the fluid.

14. The system according to paragraph 13, wherein the fluid treatmentmeans comprises means for contacting the fluid with one or more drugcompounds.

15. The system according to paragraphs 13 or 14, wherein the fluidtreatment means comprises means for contacting the fluid with one ormore gas, such as oxygen.

16. The system according to any one of paragraphs 10 to 15, furthercomprising means for securing the flow regulating means to theconnector.

17. The system according to any one of paragraphs 10 to 16, wherein theflow regulating means comprises a rotatable shaft supporting at leastone blade, said blade being adapted for extension in the longitudinaldirection of the shaft into an insertion configuration.

18. The system according to paragraph 17, wherein the blade is adaptedfor relaxation in the longitudinal direction of the shaft into a workingconfiguration.

19. The system according to paragraph 18, wherein, in the lateraldirection of the shaft, the dimension of the blade is greater in theworking configuration than in the insertion configuration.

20. The system according to any one of paragraphs 17 to 19, wherein theblade is a screw type blade.

21. The system according to any one of paragraphs 17 to 20, wherein theblade is made of a longitudinally resilient material.

22. The system according to any preceding paragraph, wherein one or bothanatomical compartments are compartments of the circulatory system.

23. The system according to any preceding paragraph, wherein the fluidis blood.

24. The system according to any preceding paragraph, wherein the systemis a ventricular assist device.

25. The system according to any preceding paragraph, further comprisinga percutaneous insertion device comprising a needle, said needlecomprising a needle body, a guide wire and a puncture head.

26. The system according to paragraph 25, wherein the puncture headcomprises a solid tip.

27. The system according to paragraph 25 or 26, wherein the dimensionsof the widest cross section of the puncture head are substantially thesame as those of the cross section of the distal end of the guide wire.

28. The system according to any one of paragraphs 25 to 27, wherein theinsertion device further comprises a dilator.

29. The system according to paragraph 28, wherein the dimensions of thewidest cross section of the puncture head are substantially the same asthose of the distal end of the dilator.

30. The system according to any one of paragraphs 25 to 29, wherein theinsertion device further comprises means for guiding a sheath.

31. An intracorporeal connector as specified in any preceding paragraph.

32. An intracorporeal flow regulating device as specified in any one ofparagraphs 10 to 21.

33. A percutaneous insertion device as specified in any one ofparagraphs 25 to 30.

34. A percutaneous method for providing fluid communication between twoanatomical compartments, the method comprising the steps of

puncturing the wall(s) separating the compartments and

inserting an intracorporeal connector through the puncture(s) for fluidcommunication between the two compartments.

35. The method according to paragraph 34, wherein the puncturing step iscarried out using an insertion device as specified in any one of claims25 to 30.

36. The method according to paragraph 34 or 35, wherein theintracorporeal connector is a connector as specified in any one ofparagraphs 1 to 30.

37. The method according to any one of paragraphs 34 to 36, furthercomprising the step of regulating the flow of fluid between the twoanatomical compartments.

38. The method according to paragraph 37, wherein the flow of fluid isregulated using an intracorporeal flow regulating device as specified inany one of paragraphs 10 to 30.

39. The method according to any one of paragraphs 34 to 38, furthercomprising the step of treating the fluid.

40. The method according to paragraph 38, wherein the treatment of thefluid is carried out using the treatment means as specified in any oneclaims 13 to 15.

41. The method according to any one of paragraph 34 to 40 wherein one orboth compartments are compartments of the circulatory system.

1. A transcatheter insertion device comprising a guide wire comprising an integrally formed puncture head.
 2. The insertion device according to claim 1, wherein the puncture head comprises a solid distal tip.
 3. The insertion device according to claim 2, wherein the puncture head has a conical distal tip.
 4. The insertion device according to claim 3, wherein the diameter at the base of the conical tip is substantially the same as the diameter of the guide wire.
 5. The insertion device according to claim 4, wherein the guide wire is capable of coiling around the puncture head.
 6. The insertion device according to claim 5, wherein the guide wire is made of a shape memory material.
 7. The insertion device according to claim 1, further comprising a dilator.
 8. The insertion device according to claim 1, further comprising a delivery sheath.
 9. The insertion device according to claim 1, further comprising an outer delivery sheath.
 10. A method for puncturing at least one anatomical wall separating two anatomical compartments using an insertion device as recited in claim
 1. 11. The insertion method according to claim 10, wherein the puncture head comprises a solid distal tip.
 12. The insertion method according to claim 11, wherein the puncture head has a conical distal tip.
 13. The insertion method according to claim 10, wherein the anatomical compartments are separated by two anatomical walls.
 14. The method according to claim 10, wherein the two anatomical compartments are two anatomically non-adjacent.
 15. The insertion method according to claim 10, comprising the step of inserting the insertion device into the patient's circulatory system until the puncture head abuts the anatomical wall to be punctured.
 16. The insertion method according to claim 10, comprising the step of pushing the two anatomical compartments into contact with each other using the insertion device.
 17. The insertion method according to claim 10, comprising the step of puncturing the wall(s) separating the compartments using the puncture head and guiding a percutanous device(s) through the puncture using the guide wire.
 18. The insertion method according to claim 10, comprising the step of preventing the puncture head from causing trauma to the patient's anatomy.
 19. The insertion method according to claim 10, wherein the system is inserted through the femoral artery and/or inferior vena cava.
 20. The insertion method according to claim 10, wherein one of the compartments is the left atrium of the heart or the aorta. 